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NeonatesAfter a fetus is delivered, it is termed a neonate (newborn). Neonates of uncertain viability, or non-viable neonates may be subjects of research only if appropriate studies on animals and non-pregnant individuals have been completed.
After a fetus is delivered, it is termed a neonate (newborn). Neonates of uncertain viability, or non-viable neonates may be subjects of research only if appropriate studies on animals and non-pregnant individuals have been completed.
Viability is defined as the ability of the fetus to survive, given the benefit of available medical therapy, to the point of independently maintaining heart beat and respiration.
Neonates of uncertain viability may be involved in research only if there is no added risk to the fetus, or the purpose of the research is to enhance the possibility of survival to the point of viability. Informed consent must be obtained from the legally competent mother or father, or either parent’s legally authorized representative.
If a fetus is determined to be non-viable, it may only be involved in research if:
The vital functions of the fetus will not be artificially maintained.
No experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will be employed.
There will be no additional risk to the neonate.
The purpose of the research is the development of important biomedical knowledge that cannot obtained by any other means.
If a fetus is viable after delivery, it is a child. Federal regulations governing research involving a viable newborn is explained under research involving children.
(END TEXT UNDER LINKS FROM PARAGRAPH 3/THE FOLLOWING IS PARAGRAPH 4 AND CONTINUED TEXT UNDER “Risk and Levels of IRB Review”)
Note: depending on the research, other subjects may be deemed as vulnerable as well. Before submitting an application to the IRB, you should understand the protections you must employ in your research protocol to protect these groups of people.
Federal regulations mandate other safeguards to protect human subjects when research involves: confidential records and/orpathological/diagnostic specimens, previously collected data, research subjects are being audio and/or videotaped, ethnographic research, or international studies (research conducted in foreign countries).
